This invention relates to a fortified food product which can be used as a dietary supplement or as an added ingredient for fortifying various food components. More particularly, this invention relates to a fortified rice bran food product that is capable of preventing and/or treating cardiovascular disease including, e.g., hypertension. In addition, this invention relates to a method of preventing and/or treating cardiovascular disease involving oral ingestion of the food product of this invention.
Cardiovascular disease is a major health issue in the United States. Several compositions and methods have been developed over the years in an attempt to prevent or treat this disease.
U.S. Pat. No. 6,126,943 (Cheruvanky et al.) discloses a method for reducing mammalian serum total cholesterol, LDL cholesterol, apolipoprotein B and triglyceride levels, by ingesting a stabilized rice bran derivative selected from the group consisting of an enzyme treated stabilized rice bran, an insolubilized fraction and mixtures thereof. The patent teaches that the rice bran used therein is rich in B-complex vitamins, vitamin E and its isomers, minerals like potassium, magnesium, and phosphorous, and several potent antioxidants.
U.S. Pat. No. 5,962,062 (Carrie, et al.) discloses a dietetically balanced milk product containing a lipid mixture based on a combination of milk fats and vegetable oils formulated so as to obtain an optimum balance of active substances in order to prevent unbalanced metabolic charges, in particular cardiovascular risks, and so that its organoleptic properties are close to those of milk. The lipid mixture may contain fatty acid oils such as EPA and DHA. The composition may also contain oils rich in vitamin E, oils rich in non-vitamin antioxidants (e.g., rice bran oil). The milk product may also be enriched with vitamins, e.g., E, A, D, C, B6, B12, folate and trace elements, e.g., iron, magnesium, and zinc.
U.S. Pat. No. 5,948,443 (Riley, et al.) discloses a total modular system of multivitamin and mineral supplementation composed of seven distinct modules for improving public health by insuring adequate intake of micronutrients needed for disease prevention and protection against nutritional losses and deficiencies. Module 4 contains aspirin or the like and is directed primarily for persons known to be at risk of coronary heart disease. The patent teaches that specific antioxidant micronutrients such as vitamins C, E, beta-carotene, selenium, copper, manganese, magnesium, folic acid, vitamin B6, and vitamin B12 enhance aspirin""s ability to reduce risk of coronary heart disease.
WO 91/17670 discloses a foodstuff which is said to have prophylactic and/or curative effects and is suitable for use in the prevention and/or cure for diseases such as cardiovascular disease and cancer. The foodstuff is composed of at least one combination of at least polyunsaturated omega-3 fatty acid and/or its esters and one or more vitamins and pro-vitamins. The omega-3 fatty acid is preferably eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA) or their esters. The vitamin component is preferably made up of beta-carotene, vitamin C and vitamin E.
EP 0699437 discloses pharmaceutical preparations containing polyunsaturated fatty acids (e.g., EPA and DHA), their esters or salts, together with antioxidant vitamins or provitamins (e.g., vitamins E, A and C and carotenes, wherein the preparations are said to be useful in the prevention and/or treatment of atherosclerosis and of cardiovascular, nervous system, skin and malignant pathologies.
U.S. Pat. No. 6,210,686 (Bell et al.) discloses a dietary supplement and method for lowering risk of heart disease, wherein the supplement includes yeast fiber, folic acid or a salt thereof, vitamin B6, vitamin B12, and vitamin E. Optionally, the supplement may contain one or a combination of other vitamins (e.g., niacinamide, vitamin C), minerals, antioxidants, fibers and other dietary supplements (e.g., protein, amino acids, choline, lecithin, omega-3 fatty acids). The patent to Bell et al. teaches that, due to the presence of folate and vitamin B6, the dietary supplement provides a second benefit of suppressing the level of homocysteine in the blood. The supplement provides a third benefit due to the presence of vitamin E which, according to the patent, preserves low density lipoproteins from oxidation.
U.S. Pat. No. 5,952,393 (Sorkin, Jr.) discloses a composition for reducing serum cholesterol in humans and animals, wherein the composition includes phytosterol and policosanol which together produce a synergistic effect in lowering serum cholesterol levels. The patent teaches that the policosanol used in the preferred embodiment of the invention is obtained from rice bran wax.
U.S. Pat. No. 6,180,660 (Whitney et al.) discloses a method for reducing or preventing the risk of first occurrence of a cardiovascular event in a subject having an average to mildly elevated level of LDL cholesterol and below average high-density lipoprotein ML) cholesterol, with no clinical evidence of coronary heart disease, comprising administering a prophylactically effective amount of a lipid altering agent such as a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor alone or in combination with another lipid altering agent such as a fibrate, or niacin, to the subject. The active ingredients used in the method can be administered in oral forms such as tablets, capsules, pills, powders, granules, elixirs, tinctures, suspensions, syrups and emulsions.
Studies have shown that folic acid and vitamin B6, taken in excess of recommended daily allowance, reduce the risk for developing heart disease by reducing levels of homocysteine. Homocysteine is associated with arterial occlusive disease.
Rice bran in and of itself has been considered for several years as an ingredient for food use because of the health benefits derived from its consumption. The bran as a by-product of rice milling has been used in the feed industry for many years, but with advanced techniques has only been recently considered as a food for human consumption. The nature of the bran is such that the remaining rice oils become rapidly oxidized so as to render it unacceptable for food. New and advanced techniques for stabilizing rice bran in the past ten years have altered its perception as an acceptable food grade product.
Several components of rice bran are desirable for the human diet. Rice bran protein has a high nutritional value that is highly digestible and is hypoallergenic. The proximate composition of stabilized, parboiled, defatted rice bran as stated in Saunders, R. M., xe2x80x9cThe Properties of Rice Bran as a Foodstuffxe2x80x9d, Cereal Foods World, 35:632 (1990), is as follows: moisturexe2x80x946 to 9%, proteinxe2x80x9423 to 27%; fatxe2x80x940.5 to 1.5%, crude fiberxe2x80x9416 to 20%, and ashxe2x80x9411 to 14%. The fatty acid composition of the rice bran oil consists mainly of oleic, palmitic, and linoleic acids. In addition to the fatty acids, naturally occurring vitamins and minerals are present in varying amounts depending on growing conditions and milling methods. Vitamins and minerals present include vitamin A, thiamine, riboflavin, niacin, pyridoxine, panothenic acid, biotin, myoinositol, choline, para-aminobenzoic acid, folic acid, vitamin B12, vitamin E, calcium, iron, magnesium, manganese, phosphorus, potassium and zinc. The major carbohydrates present are cellulose, hemicelluloses (pentosans), and starch. Beta-glucans are also present, forming part of the dietary fiber complex. Total dietary fiber content ranges from about 44% to about 51%, with the soluble fiber constituting from 2.4% to 2.9% of that total (see Marshall, W. E. and Wadsworth, J. J (editors), Rice Science and Technology, Marcel Dekker, Inc., New York, pp. 384-389 (1994)).
Due to the overall nutritional value of rice bran due to the high dietary fiber and low fat concentration, there has been considerable research in the last ten years on the use of rice bran in the diet for reducing the risk of cardiovascular disease. In a study reported in Gerhardt, A. L. and Gallo, N. B., xe2x80x9cEffect of a Processed Medium Grain Rice Bran and Germ on Hypercholesterolemiaxe2x80x9d, American Association of Cereal Chemists Meeting, Washington, D.C. (1989) (poster presentation), it was determined that rice bran was at least as effective in lowering cholesterol in male subjects as oat bran.
The American Heart Association (AHA) dietary guidelines for Americans has emphasized the importance of consuming a variety of fiber sources to obtain the different types of fibers found in foods. The AHA also states that fiber is important for gastrointestinal health as well as for cholesterol-lowering benefits. The AHA recommends a total dietary fiber intake of 25 to 30 grams from foods per day to maximize the cholesterol-lowering impact of a fat-modified diet. Current dietary fiber intakes among adults in the United States average about 15 grams or half the AHA-recommended intake of fiber per day (see Alaimo, K., McDowell, M., Briefel, R, Bischof, A, Caughman, C., Loria, C., and Johnson, C., xe2x80x9cDietary Intake: Vitamins, Minerals and Fiber of Persons Age Two Months and Over in the United States: Third National Health and Nutrition Examination Survey: Phase 1, 1988-91., Advance Data. (1994) 258:1-28.
Other dietary ingredients have also been recommended by the scientific community for the treatment of cardiovascular disease. These ingredients include vitamin E, vitamin C, vitamin B6, vitamin B12, vitamin B1, niacin, folic acid, and omega 3 fatty acids from fish oil.
Numerous studies have been conducted suggesting that the omega 3 fatty acids in fish oil, including eicosapentaenoic acid (EPA) and decosahexaenoic acid DHA), are beneficial to cardiovascular health. While not conclusive at this time, the studies have shown the lowering of LDL cholesterol levels and triglyceride levels. The mechanism is not clear as yet, but the results of an Italian study by GISSI-Prevenzione that included 11,000 blood clot patients who were studied for 2-3 years showed that a daily fish oil supplement containing 1 gram of omega 3 fatty acid reduced the death rate about 15% and reduced the risk of heart attacks by 50% (see Berlingske Tidende article, xe2x80x9cFish Can Save Heart Patientsxe2x80x9d, week of 21/2000, Copenhagen, Denmark). Health organizations around the world, including the Food and Drug Administration (FDA), have recognized the possible benefit of omega-3-fatty acids from fish oil for the treatment of coronary heart disease (CHD). The concentrations recommended vary from organization to organization, but the range is from about 150 milligrams to about 2000 milligrams per day of omega-3-fatty acids.
Other nutrients that have been recommended for the treatment of cardiovascular disease also have ranges of recommended concentrations. In a survey of the literature, minimum levels for the nutrients are as follows: vitamin Exe2x80x94100 IU/day, vitamin Cxe2x80x94250 mg/day, vitamin B6xe2x80x9412.5 mg/day, vitamin B12xe2x80x9475 mcg/day, vitamin B1 xe2x80x9412.5 mg/day, niacinxe2x80x9425 mg/day, and folic acidxe2x80x940.25 mg/day. Four times the concentrations listed equals the optimal concentrations per day suggested for cardiovascular health (see Balch, J. F. and Balch, P. A., xe2x80x9cPrescription for Nutritional Healingxe2x80x9d, Avery Publishing Group, Garden City Park, N.Y., page 6 (1997)).
In consideration of the possible health benefits in the treatment of coronary heart disease or in maintaining cardiovascular health with a diet high in fiber, low in fat, and adequate intakes of the nutrients vitamins B1, B2, B6, B12, C, E, niacin, folic acid, and omega-3-fatty acids from fish oil, a food product that contains all of those ingredients in specific concentrations would be of value to consumers.
While there are naturally occurring nutrients in rice bran such as vitamins B1,B6, B12, and E, niacin, and folic acid, the concentrations vary depending on growth conditions of the rice and processing methods. Enzymes must be destroyed to prevent oxidation of the fat components of the rice bran and vitamins may also be destroyed in the process. Due to the variable concentrations of the natural vitamins, it would be desirable to fortify rice bran with these ingredients in controlled concentrations for treatment of cardiovascular disease. It would be further desirable to fortify rice bran with ingredients such as vitamin C and omega 3 fatty acids from fish oil that are not naturally present in rice bran, but would contribute significantly to the treatment of cardiovascular disease.
Therefore, a primary object of this invention is to provide a rice bran food product which has been fortified with controlled concentrations of cardiovascular-improving nutrients.
A further object of this invention is to provide a method for treating and/or preventing cardiovascular disease in animals, particularly humans, using a rice bran food product which has been fortified with controlled concentrations of cardiovascular-improving nutrients.
A still further object of this invention is to provide a food article composed of a rice bran food product which has been fortified with controlled concentrations of cardiovascular-improving nutrients.
These and other objects are achieved in the present invention.
The present invention provides a functional food product that is designed to prevent heart disease by providing nutrients which prevent and treat hypertension and coronary heart disease. The food product contains vitamins such as vitamins E, C, B6, B12, B1, and niacin, folic acid (folate), and the omega-3-fatty acid(s) from fish oil, with rice bran as the carrier or base for the product. The properties of the rice bran also contribute to the cardiovascular health-providing benefits of the product because of the rice bran""s inherent fiber and trace minerals. The food product contains the nutrients in quantities that promote a healthy cardiovascular system and that will prevent, and, in some cases, reverse the effects of coronary heart disease in progress.
Thus, one aspect of the present invention is directed to a fortified rice bran food product which is effective in preventing and/or treating cardiovascular disease and contains in admixture:
(a) rice bran as a carrier;
(b) at least about 12.5 milligrams of vitamin B1 per 30 grams of the rice bran;
(c) at least about 250 milligrams of vitamin C per 30 grams of the rice bran;
(d) at least about 12.5 milligrams of vitamin B6 per 30 grams of the rice bran;
(e) at least about 75 micrograms of vitamin B12 per 30 grams of the rice bran;
(f) at least about 100 International Units of vitamin E per 30 grams of the rice bran;
(g) at least about 0.25 milligrams of folic acid per 30 grams of the rice bran; and
(h) at least about 250 milligrams of omega-3-fatty acids per 30 grams of the rice bran.
The fortified rice bran of this invention is preferably in the form of a stabilized powder that is easily used as a dietary supplement or that can be added as an ingredient to a variety of foods to fortify the levels of the named nutrients in the food. Thus, a further aspect of this invention is directed to a food article containing the fortified rice bran food product.
The present invention also provides a method of preventing and/or treating cardiovascular disease in an animal, involving the step of orally administering a therapeutically effective amount of the food product of this invention to the animal for a therapeutically effective period of time.